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22,295 catalysts · 4,728 grant · 4,406 device 510k · 3,230 8k filing · 3,188 approval · 2,000 device pma · 2,000 device recall
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22,295 catalysts · 4,728 grant · 4,406 device 510k · 3,230 8k filing · 3,188 approval · 2,000 device pma · 2,000 device recall
Sponsor: JANSSEN BIOTECH. Form: INJECTABLE. Route: INJECTION
Sponsor: JANSSEN BIOTECH. Form: INJECTABLE. Route: INJECTION
Sponsor: AVYXA HOLDINGS. Form: POWDER. Route: INTRAVENOUS
Product code: CBK. Advisory committee: Anesthesiology. Type: Traditional
Product code: JCX. Advisory committee: General, Plastic Surgery. Type: Special
Product code: PSY. Advisory committee: Pathology. Type: Traditional
Product code: KZH. Advisory committee: General Hospital. Type: Traditional
Product code: OAP. Advisory committee: Physical Medicine. Type: Traditional
Product code: FEB. Advisory committee: Gastroenterology, Urology. Type: Special
Product code: HRX. Advisory committee: Orthopedic. Type: Traditional
Product code: HSN. Advisory committee: Orthopedic. Type: Traditional
Sponsor: PF PRISM CV. Form: TABLET. Route: ORAL
Sponsor: PF PRISM CV. Form: CAPSULE. Route: ORAL
Sponsor: REMPEX. Form: POWDER. Route: INTRAVENOUS
Sponsor: FRESENIUS KABI USA. Form: INJECTABLE. Route: INTRAVENOUS
Product code: KTT. Advisory committee: Orthopedic. Type: Traditional
Product code: MAI. Advisory committee: Orthopedic. Type: Special
Product code: JAK. Advisory committee: Radiology. Type: Traditional
Product code: MBI. Advisory committee: Orthopedic. Type: Special
Product code: GAP. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: GEH. Advisory committee: General, Plastic Surgery. Type: Special
Sponsor: ASTRAZENECA UK LTD. Form: INJECTABLE. Route: INJECTION
THERACARE Cold Hot Medicated Patch, Menthol 5%, 5 patches per box, Manufactured for: Veridian Healthcare, LLC, Gurnee, IL 60031 NDC 71101-954-05, UPC 8 45717 00818 1 — Reason: cGMP Deviations — Status: Terminated
ABSORBINE jr. Extra Large BACK PATCH, Menthol 5%, 1 extra large patch per box, Distributed By: Absorbine Jr., LLC, Chattanooga, TN 37402 UPC 8 89476 41218 6, UPC 8 89476 41236 0 — Reason: cGMP Deviations — Status: Terminated
PARCHE LEON PAIN RELIEVING HOT PATCH, Camphor 3%, Menthol 1.25%, Capsaicin 0.025%, 6 patches per box, Distributed by: Pharmadel LLC, Georgetown, DE 19947 NDC 55758-039-01, UPC 8 59424 00433 6 — Reason: cGMP Deviations — Status: Terminated
THERACARE MAXIMUM STRENGTH PAIN RELIEF 4% LIDOCAINE PATCH, a) 1 patch (NDC 71101-001-24, UPC 8 45717 00878 5) and b) 6 patches (NDC 71101-001-06, UPC 8 45717 01056 6), Manufactured for: Veridian Healthcare, LLC, Gurnee, IL 60031 — Reason: cGMP Deviations — Status: Terminated
LILAS Feminine Pain Relief Patch, Menthol 10%, a) 5 patches per box (UPC 7 87099 48212 1) and 10 patches per box (UPC 7 87099 48211 4), Distributed by: Lilas Wellness, Inc., Beaverton, Oregon 97008-7105 — Reason: cGMP Deviations — Status: Terminated
LICEOUT, Liquid Lice Treatment for Human Use, Contents: 1 FL. OZ. (29.6 mL) per sachet, Distributed By: Bob Barker Company, Inc., 7925 Purfoy Road, Fuquay-Varina, NC 27526. NDC: 53427-124-01 — Reason: CGMP violations. — Status: Ongoing
EQUATE MAXIMUM STRENGTH LIDOCAINE PAIN RELIEVING PATCH Lidocaine 4% Topical Anesthetic, 6 patches per box PATCHES, LIDOCAINE 4%, Distributed by: Walmart Inc., Bentonville, AR 72716 NDC 79903-106-06 — Reason: cGMP Deviations — Status: Terminated
JR WATKINS COOLING PAIN RELIEF PATCHES, Menthol 7.5%, 5 patches per box, Distributed By: J.R. Watkins, LLC, Oakland, CA 94612 UPC 8 56294 00878 5 — Reason: cGMP Deviations — Status: Terminated
Cooling Menthol Extra Strength Pain Relief Patch, Menthol 7.5%, packaged in box of 5, Distributed by J.R. Watkins LLC, Oakland CA 94612 UPC 8 56294 00878 5, NDC 72342-100-05 — Reason: cGMP Deviations — Status: Terminated
ABSORBINE jr ULTRA STRENGTH PAIN PATCH, Menthol 6.5%, 1 patch per box, Distributed By: Absorbine Jr. LLC, Chattanooga, TN 37402 UPC 8 89476 41318 3, UPC 8 89476 41336 7 — Reason: cGMP Deviations — Status: Terminated
CHEEKY BONSAI PAIN RELIEF PATCHES, Menthol 10%, 4 patches per box, Distributed by Cheeky Bonsai, San Francisco, CA UPC 8 60006 57564 9 — Reason: cGMP Deviations — Status: Terminated
ABSORBINE JR PAIN RELIEVING KNEE PATCH, Camphor 7%, Menthol 7%, packaged in a) 1 patch (UPC 8 89476 41251 3) and b) 6 patches (UPC 8 89476 41306 0), Distributed By: Absorbine Jr., LLC, Chattanooga, TN 37402 — Reason: cGMP Deviations — Status: Terminated
HealthWise PERIOD PATCH Menstrual Pain Relief, Menthol 10%, 10 patches per box, Manufactured for Veridian Healthcare, LLC, Gurnee, IL 60031 NDC 71101-947-10, UPC 8 45717 01072 6 — Reason: cGMP Deviations — Status: Terminated
LICEOUT, Liquid Lice Treatment for Human Use, Contents: 128 FL OZ. (3785.4 mL mL) per jug, Distributed By: Bob Barker Company, Inc., 7925 Purfoy Road, Fuquay-Varina, NC 27526. NDC: 53247-124-02 — Reason: CGMP violations. — Status: Ongoing
Product code: MPA. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: DQK. Advisory committee: Cardiovascular. Type: Traditional
Product code: IZF. Advisory committee: Radiology. Type: Traditional
Product code: QJP. Advisory committee: Cardiovascular. Type: Traditional
Product code: DQY. Advisory committee: Cardiovascular. Type: Special
Product code: NHA. Advisory committee: Dental. Type: Traditional
Product code: HWC. Advisory committee: Orthopedic. Type: Abbreviated
Product code: MRW. Advisory committee: Unknown. Type: Special
Product code: QRA. Advisory committee: Neurology. Type: Special
Product code: EHD. Advisory committee: Dental. Type: Traditional
Product code: JOJ. Advisory committee: General Hospital. Type: Special
Product code: JWH. Advisory committee: Orthopedic. Type: Traditional
Product code: CGX. Advisory committee: Clinical Chemistry. Type: Traditional
Product code: MUJ. Advisory committee: Radiology. Type: Traditional